SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for SNP rs3751143

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

There are 2 clinical trials

Clinical Trials


1 Pure-Heart-1: A P2X7R Single Nucleotide Mutation Promotes Chronic Allograft Vasculopathy

Heart transplantation (HT) is a lifesaving procedure for patients with end-stage heart failure and provides a better survival and quality of life if compared to medical treatment. HT is subject to alloimmune response, which, if left uncontrolled, is capable of jeopardizing long-term cardiac function. Advances in immunosuppression have enhanced the survival of HT patients. Nearly 2500 HT per year have been performed in the US during the last 10 years and despite significant improvements, long-term survival rates remain poor. More than 20% of patients do not survive more than 3 years, and those who survive are afflicted by long-term complications of alloimmunity and chronic immunosuppression. Life expectancy of patients who lose cardiac allografts is dramatically poor due to the absence of any therapeutic tool apart from re-transplantation, which is plagued by poor outcomes. The identification of novel therapeutic targets is thus mandatory. ATP/P2X7R signaling in T cells is highly relevant for cardiac allograft survival. ATP is a small molecule present at high concentrations inside cells; it is released as extracellular ATP (eATP) following cell damage or death where it acts as a danger signal. ATP is sensed by the P2X receptors (seven receptors named P2X1-7), mainly expressed by T lymphocytes. We have recently demonstrated that the ATP/P2X7R axis has a key role in cardiac allograft survival in humans and mice. Cardiac allograft vasculopathy (CAV) is a major limiting factor for HT survival; indeed CAV occurs in 50% of HT recipients by 5 years after transplantation and invariably results in allograft failure. CAV is clearly of immunological origin, as syngeneic murine grafts do not develop it. Once CAV occurs, the most definitive treatment is re-transplantation, but survival remains poor. We hypothesize that a single nucleotide polymorphysm (SNP) loss-of-function P2X7R mutation (p.Glu496Ala / c.1513A>C, rs3751143) generates a compensatory upregulation of the other purinergic receptors (P2XsR), thus creating a state of hypersensitivity to eATP. This eATP hypersensitivity results in an abnormal generation of Th1/Th17 cells, that leads to CAV and early cardiac allograft loss. Our study will answer a fundamental question: What is the effect of the P2X7R loss-of-function mutation on the immune system? Our goal is to generate the first targeted-therapy for a selected group of cardiac transplant recipients.

NCT02082821
Conditions
  1. Cardiac Allograft Vasculopathy
MeSH:Vascular Diseases

We hypothesize that a single nucleotide polymorphysm (SNP) loss-of-function P2X7R mutation (p.Glu496Ala / c.1513A>C, rs3751143) generates a compensatory upregulation of the other purinergic receptors (P2XsR), thus creating a state of hypersensitivity to eATP.

Loss-of-function single nucleotide mutations (SNPs) have been detected for P2X7R gene; particularly the Glu496 to Ala 1513A>C (rs3751143) P2X7R loss-of-function mutation is relatively common (1-3% of individuals are mutated omozygous and 25% are heterozygous).

To test this hypothesis, we will follow two main paths: i) we will evaluate in the CTOT-05 cohort of cardiac transplant recipients the effect of the Glu496 to Ala 1513A>C (rs3751143) P2X7R loss-of-function mutation on clinical end points (development of coronary artery vasculopathy, death, re-transplantation or re-listed for transplantation, any rejection) in the first year post transplant; ii) we will explore in vivo and ex vivo in the CTOT-05 cohort of cardiac transplant recipients the effects of P2X7R loss-of-function mutation on the immune system.

Primary Outcomes

Description: nominal change from baseline to 1 year in percent atheroma volume measured by intravascular ultrasound

Measure: Cardiac Allograft Vasculopathy

Time: 1 year

Secondary Outcomes

Description: Death re-transplant biopsy proven acute rejection antibody mediated rejection cellular rejection; treated rejection hemodynamic compromise-associated rejection chronic allograft vasculaopathy at 12-months total atheroma volume; change in average maximal intimal thickness rapid progressive chronic allograft vasculaopathy (change in maximal intimal thickness) ≥0.5 mm in the first year (intravascular ultrasound) histological changes of antibody mediated rejection (Immunohistochemistry).

Measure: Heart Rejection or Patient Death

Time: 6 months; 12 months

2 A Randomised, Placebo-controlled, Double-blind Trial of the Antidepressant Efficacy of a Novel CNS-penetrant P2X7 Receptor Antagonist, JNJ-54175446, in People With Major Depressive Disorder, an Incomplete Response to Monoaminergic Antidepressant Drugs, and a Biomarker Profile Predictive of Active P2X7 Signalling

Depression is one of the most important causes of disability in the world today, with major personal, social and economic costs. Although some moderately effective drug treatments are already available, about a third of patients with major depressive disorder (MDD) remain depressed despite current treatment. There is growing evidence that inflammation - the response of the body's immune system to physical and social stresses - can cause depressive symptoms in some patients. It is therefore predicted that anti-inflammatory drugs could have anti-depressant effects and the research team aims to test this using a new drug, JNJ-54175446, which blocks the activity of a receptor called P2X7. P2X7 is present on many immune cells and plays a key role in the release of inflammatory molecules during stress, which may be linked to stress-related depression. The research team will recruit approximately up to 142 participants with MDD to this clinical trial. Patients will have moderate-severe depressive symptoms despite ongoing treatment with a conventional anti-depressant drug, and they will have blood test results at screening that indicate they are likely to have active P2X7 signalling in the brain. Eligible participants will be randomly allocated to receive either 50mg/day JNJ-54175446 or placebo for 8 weeks. Participants will be assessed at weeks 2, 5 and 8 using a standard clinical depression scale and the scores compared between those treated with placebo and those treated with JNJ-54175446. To understand more about the effects of JNJ-54175446 on the immune system and the brain, patients will also complete additional blood tests, questionnaires and magnetic resonance imaging (MRI) brain scans at different visits throughout the trial. The trial will be carried out across 5 centres in the UK.

NCT04116606
Conditions
  1. Depressive Disorder, Major
  2. Inflammation
Interventions
  1. Drug: Active JNJ-54175446
  2. Drug: Placebo
MeSH:Inflammation Depressive Disorder Depression Depressive Disorder, Major
HPO:Depressivity

3. Presence of two copies of the loss-of-function C allele at rs3751143, and/or has one copy of the loss-of-function A allele at rs1653624 in the P2RX7 gene.

Primary Outcomes

Description: The Montgomery Asberg Depression Rating Scale (MADRS), a researcher-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. (Visit 4)

Measure: Change from baseline in total score on the MADRS scale at week 8

Time: At baseline and at 8 weeks of treatment

Secondary Outcomes

Description: The Montgomery Asberg Depression Rating Scale (MADRS), a researcher-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

Measure: Change from baseline in total score on the MADRS scale

Time: At baseline, 2 and 5 weeks of treatment

Description: Perceived Stress Scale is a questionnaire measure of recent or current social stress. This scale ranges from 0 to 40; scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress.

Measure: Change in scores on Perceived Stress Scale

Time: At baseline, 2, 5 and 8 weeks of treatment

Description: Snaith-Hamilton Pleasure Scale. SHAPS is an instrument developed for the assessment of hedonic capacity and consists of 14-items. Four major domains are covered in the scale, namely interest/pastimes, social interaction, sensory experience, and food/drink. The score range is 0-14. The higher the score the lower the ability to experience pleasure of the patient.

Measure: Change in scores on SHAPS

Time: At baseline, 2, 5 and 8 weeks of treatment

Description: Chalder Fatigue Questionnaire (CFQ). The Fatigue Scale, sometimes referred to as the Chalder Fatigue Questionnaire, is a self-administered questionnaire for measuring the extent and severity of fatigue within both clinical and non-clinical, epidemiological populations. The respondent's global score can range from 0 to 33. The global score also spans two dimensions-physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11).

Measure: Change in scores on CFQ

Time: At baseline, 2, 5 and 8 weeks of treatment

Description: Quick Inventory of Depressive Symptomatology (QIDS-SR16). The QIDS-SR16 is designed to assess the severity of depressive symptoms and is sensitive to change due to with medications, psychotherapy, or other treatments. Participants will provide responses to each item of this instrument with a 4-point Likert scale, with scores ranging from 0-3 for each item. The total score ranges from 0 to 27. Using a scale of severity of depression of none, mild, moderate, severe, and very severe, corresponding QIDS-SR16 total scores are none 1 to 5, mild 6 to 10, moderate 11 to 15, severe 16 to 20 and very severe 21 to 27.

Measure: Change in scores on QIDS-SR16

Time: At baseline, 2, 5 and 8 weeks of treatment

Description: Generalized Anxiety Disorder 7 (GAD-7). GAD-7 is a self-reported questionnaire for screening and severity measuring of GAD. GAD-7 has seven items, which measure severity of various signs of GAD according to reported response categories with assigned points. Assessment is indicated by the total score, which made up by adding together the scores for all 7 items. The score ranges from 0 to 21. Using a scale of severity of anxiety of none, mild, moderate and severe, corresponding to GAD-7 total scores are none 0 to 4, mild 5 to 9, moderate 10 to 14 and severe 15 to 21.

Measure: Change in scores on GAD-7

Time: At baseline, 2, 5 and 8 weeks of treatment

Description: Participants will be asked to self-assess their depression using the Beck Depression Inventory scale (BDI). BDI is a 21-question multiple-choice self-report inventory, widely used for assessment of depression, including in the NIMA BIODEP study, with a score range of 0-63. Each of the 21 items is rated by the participant on a 4 point scale.

Measure: Change in score on participant self-reported depression scale

Time: At baseline and at 8 weeks of treatment

Description: Revere-D is an application developed by Johnson and Johnson, and consists of a battery of eight validated cognitive tasks that assesses cognitive functions, such as memory and learning, that do not involve cognitive processing of emotionally salient stimuli.

Measure: Change in scores in the cognitive function test ReVeRe-D

Time: At baseline, 2, 5 and 8 weeks of treatment

Description: The continuous performance test is a computerised test of sustained attention which provides a measure of cognitive fatigue.

Measure: Change in scores in Continuous performance test

Time: At baseline, 2, 5 and 8 weeks of treatment

Description: The emotional test battery will consist of 3 validated computerised tasks which are used to assess cognitive functions that involve processing emotionally salient stimuli, such as human faces expressing emotional states.

Measure: Change in scores in Emotional Test battery

Time: At baseline and 2 weeks of treatment

Description: Brain structure and function will be assessed using fMRI/MRI

Measure: Change in Brain structure and function

Time: Baseline and at 8 weeks fo treatment

Description: Heart rate variability will be measured for 15 minutes during rest and whilst completing one of the cognitive tasks.

Measure: Change in heart rate variability

Time: Baseline and at 8 weeks fo treatment

Other Outcomes

Description: Participants will be asked to provide saliva samples before treatment commencement and during the last week of treatment in order for the cortisol levels to be analysed.

Measure: Change in Salivary cortisol levels as a measure of biological stress

Time: Samples collected within 7 days prior to Baseline visit and within 7 days prior to visit 4

Description: Blood samples will be collected for the analysis of cytokine and chemokine levels with a multiplex immunoassay using the MSD Multi-spot assay system with the Cytokine Panel 1, Proinflammatory panel 1 and Chemokine panel 1 kits providing concentration of all analytes of the panel in pg/ml.

Measure: Measurement of peripheral blood peripheral cytokine and chemokine levels

Time: Baseline and at 8 weeks fo treatment

Description: The immune cellular content of the blood samples will be analysed with mass cytometry using the commercial kit Maxpar® Direct™ Immune Profiling Assay.

Measure: Measurement of peripheral blood immunophenotypes

Time: Baseline and at 8 weeks fo treatment


HPO Nodes


HP:0000716: Depressivity
Genes 461
EZR TGIF1 ND6 PROK2 COL7A1 NODAL TOR1A CACNA1G VPS35 NSUN2 GTF2IRD1 SLC20A2 CHD7 COL7A1 TACR3 SHH ST3GAL3 ARVCF NR4A2 CEP85L RREB1 AARS2 GNA11 ATXN10 FMO3 TCF4 POLG ATXN8OS AIMP1 C9ORF72 LRRK2 PSAP FGF8 CYP27A1 DCTN1 GAS1 GBA TGFBR2 PODXL FOXH1 CLIP2 VPS13C TBK1 HIRA CC2D1A GP1BB GNAS PDGFRB VAPB ABCA7 MEN1 COX1 DLL1 HARS1 SEC24C SIX3 GABRG2 ELN PIK3CA PAH POLG GNAS TWNK GNRH1 THOC2 MBOAT7 VCP PMS2 FOXH1 SLC6A4 GABRG2 POLG PDGFB CBL CDON AP2S1 GAS1 MAPT TARDBP TRNW TMEM106B MATR3 TTC19 DNAJC5 TRNL1 BCS1L CBS FRRS1L KRAS JRK GLA CDON PDGFRB SHH DISP1 PRPH ZIC2 AMACR DISP1 SLC25A4 MAN1B1 DNA2 GBA GSN FOXH1 GNRHR TDGF1 KDM5B FAN1 ADH1C VPS13A XK CEP78 TRNS1 GLI2 FGF8 TRNH ATP13A2 NEFH CSF1R COASY FMR1 ATXN8 ATXN2 FGFR1 ARSA CLCN4 USP8 TRNS2 TBC1D7 ND1 ND4 HTR2A DISP1 PANK2 STAG2 CCNF GPR101 SIX3 TRNQ PRNP ZC3H14 DCPS CISD2 HTT HNMT SLC2A3 MSH6 USH1C DNMT1 VCP ZIC2 CACNA1H MSTO1 C9ORF72 KCNJ2 HMBS MSH2 MED23 FGF8 KCNT1 PER2 SHH USH2A USH1G DRD2 PTPN22 NODAL ERBB4 PPT1 PTCH1 DAO ZIC2 TRNF CDH23 THOC2 MED25 HTT DLL1 LINS1 WASHC4 TRNS2 TUSC3 TET3 PLA2G6 MYO7A CDON CHCHD10 PSEN1 EPM2A PINK1 ARSG EPHA4 CHCHD10 CHMP2B ANOS1 CDKN1B PDZD7 MAN2B1 PTCH1 SLC45A1 DNAJC6 GLI2 PER3 ATXN10 TAF15 ADGRV1 SNCA HLA-DQB1 SLC2A1 FGF8 C19ORF12 TSC2 PRKN OPTN POLG2 MAPK1 CARS1 POLG WDR11 PDCD1 FGFR1 PPP2R2B PCDH15 FLT4 TECR SGCE DNAJC13 COQ2 B3GALNT2 RPS20 GLE1 SQSTM1 SPRY4 CACNA1G FA2H CDKN2C NHLRC1 SNCA UNC13A DGUOK CPOX TBK1 CDH23 FGF14 PFN1 PRNP MAPT CLRN1 JMJD1C RSRC1 TBX1 FBXO31 PTS EPCAM PON2 TNIK TBL2 TBX1 PDGFRB ATRX TAC3 PANK2 TARDBP FMR1 EHMT1 PRNP CLIP1 RFC2 DCTN1 SARS1 TRAPPC9 FGF14 SNCA RRM2B LIMK1 KISS1 NOTCH3 XPR1 FIG4 TWNK SIX3 CRBN GLI2 SMPD1 HLA-DQB1 CRKL PMS1 CDKN2B HTRA2 SPAST HS6ST1 PDE11A C9ORF72 MST1 SLC18A2 FGFR1 RPS6KA3 WFS1 CDON DNMT1 SRSF2 LMNB1 PRSS12 GABRB3 EDC3 POLG TRNS1 ZIC2 CLCN4 KCTD17 GBA TK2 CFAP410 MLH1 VCP COX2 GABRA1 FOXH1 PARK7 SYNJ1 COX3 EIF4G1 PON1 HNRNPA1 LRRK2 IDUA FGF8 GRIK2 POLG PRKCG NDST1 TGIF1 DUSP6 ATXN2 RRM2B SMC1A WFS1 PRNP TDGF1 TSC1 STX16 GIGYF2 ATP1A3 PTCH1 ATP1A3 HMBS GLI2 ARMC5 KCTD17 SEMA4A GLUD2 GAS1 HTT TET2 TBP GAS1 ASXL1 DMPK CASR PDGFB PRNP CIB2 UFD1 COQ2 TGIF1 GLT8D1 TREX1 VCP ARMC5 GTF2I MECP2 TWNK KISS1R LMAN2L GRIN2A PTCH1 RUNX1 ANG PIGC NSMF GNAS TWNK TDGF1 ANXA11 SGCE GCH1 FUS AIP TGIF1 BMPR1A UBQLN2 CTSF OCRL PON3 CHMP2B METTL23 ESPN CLN6 TDGF1 TRNL2 IQSEC1 TRNL1 PRKACA PRNP C9ORF72 DLL1 GRN PGAP1 GDAP2 TRNN SHH MSTO1 SIX3 SNCAIP MLH3 ND5 SRPX2 STAG2 NEK1 WHRN TBP TREM2 GNAS MMP1 C12ORF4 FMN2 PPARGC1A SQSTM1 HLA-DRB1 PINK1 ATP7B TREM2 BCR TOR1A SOD1 C9ORF72 NODAL GNAS DCTN1 PRKAR1A AFG3L2 GPR35 BAZ1B DLL1 PLA2G6 CDKN1A MAN2B1 COMT CRADD PROKR2 MAPT FUS MYO7A JPH3 NODAL FGF17 PAH UCHL1 DISP1 ATXN8OS